THE SPANNER TEMPORARY PROSTATIC STENT
FDA premarket approval P060010/S008 · decided 2009-12-09
Approval details
- PMA number
- P060010
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE SPANNER TEMPORARY PROSTATIC STENT
- Generic name
- Stent, urethral, prostatic, semi-permanent
- Applicant
- Srs Medical
- Date received
- 2009-10-16
- Decision date
- 2009-12-09
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- NZC
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- North Billerica, MA
- Statement
- APPROVAL FOR CHANGES TO THE DESIGN OF THE DISTAL ANCHOR INCLUDING MOLDING THE ANCHOR FLAT, REPLACING THE WIRE REINFORCEMENT WITH AN INCREASE IN DUROMETER OF THE SILICONE, AND ADDING TITANIUM DIOXIDE AS A WHITE COLORANT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CT3000Pro (K212830) | Srs Medical | 2021-12-21 |